Single-use vials for administering eye drops

ABSTRACT

Single-dose vials for liquid solutions (e.g., liquid medicaments) can be designed to be used in conjunction with a medication regimen. A single-dose vial may include a removable member that prevents a liquid solution from escaping, but also allows an individual (e.g., a patient or a medical professional) to readily administer the liquid solution. A single-dose vial could include one or more discrete capsules that include the same or different liquid solutions. For example, multiple capsules could be arranged within a vial so that different liquid solutions are simultaneously or sequentially ejected following removal of the removable member and application of pressure to the multiple capsules (e.g., due to the individual squeezing the vial). Multiple vials can also be connected to one another in a strip configuration, which allows the individual to more easily adhere to a medication regimen that requires multiple doses over a period of time.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a continuation application of U.S. application Ser.No. 16/310,398, filed on Dec. 14, 2018, which is a National PhaseApplication of PCT International Application No. PCT/US17/037665, filedon Jun. 15, 2017, which published as WO 2017/218767 on Dec. 21, 2017,which claims priority to U.S. Provisional Patent Application No.62/350,654, filed on Jun. 15, 2016, all of which are incorporated byreference herein in their entirety.

RELATED FIELD

Various embodiments concern vials of liquid solution and, morespecifically, single-use vials that house one or more capsulescontaining a liquid solution to be administered to one or both eyes.

BACKGROUND

Approximately thirty percent of medication prescriptions are neverfilled, and nearly fifty percent of medications for chronic diseases(i.e., long-lasting conditions) are not taken as prescribed.Non-adherence to medication regimens has dramatic effects on the healthof the individuals and the healthcare costs for society as a whole. Infact, non-adherence has been estimated to cost the U.S. health caresystem nearly $200 billion annually.

However, compliance with a medication plan (also referred to as a“medication regimen”) may be instrumental to improving or maintainingthe health status of an individual. For example, compliance with anophthalmological medication regiment may be vital for preventing visualloss resulting from chronic eye conditions such as glaucoma. But almostseventy-five percent of patients admit to some form of non-compliantbehavior, over thirty percent of patients do not fill theirprescriptions, and nearly fifty percent of patients discontinue theirprescriptions within six months of it being prescribed.

BRIEF DESCRIPTION OF THE DRAWINGS

The patent or application file contains at least one drawing executed incolor. Copies of this patent or patent application publication withcolor drawing(s) will be provided by the Office upon request and paymentof the necessary fee.

Embodiments of single-use vials for administering liquid medicament(s)(also referred to as “the technology”) are illustrated by way of exampleand not limitation in the accompanying drawings, in which likereferences indicate similar elements. Various objects, features, andcharacteristics of the technology will become more apparent to thoseskilled in the art from a study of the Detailed Description inconjunction with the accompanying drawings.

FIG. 1 depicts a conventional medication regimen that requires differentliquid solutions (some or all of which may include medications) beapplied as eye drops at different times throughout the day.

FIG. 2 includes a graph illustrating that a majority of patients who areprescribed a medication regimen discontinue adherence in less than ayear.

FIG. 3A depicts a strip of multiple single-use vials (also referred toas “single-dose vials”) containing liquid solution(s) that can beapplied to one or both eyes.

FIG. 3B depicts an arrangement of multiple bubbles containing liquidsolution(s) that can be applied to one or both eyes.

FIG. 4A depicts a series of single-use vials that include multipleliquid solutions in discrete capsules that can be simultaneously orsequentially administered.

FIG. 4B depicts how microfluidic flow channels can be used to guideliquid solution from one or more discrete capsules to an applicator tip.

FIG. 5 depicts a flow diagram of a process for manufacturing single-dosevials that include one or more discrete capsules, which each include aliquid solution to be administered by an individual.

FIG. 6 depicts a flow diagram of a process for administering a liquidsolution (e.g., a saline-based solution that includes a medication) froma single-dose vial.

The figures depict various embodiments of the technology for the purposeof illustration only. While specific embodiments are shown in thedrawings, the technology is amenable to various modifications andalternative forms. Those skilled in the art will recognize thatalternative embodiments may be employed without departing from theprinciples of the technology.

DETAILED DESCRIPTION

A medication regimen is a plan or a regulated course of action(s) (e.g.,diet and exercise) that is designed to improve or maintain the healthstatus of an individual. For example, a medication regimen may identifya medication that is to be administered by the individual, the frequencyand/or time that dose(s) of the medication are to be administered, theamount/quantity of each dose, etc. Non-adherence can (and often does)have a severe impact on the individual's health.

For example, strict adherence to an ophthalmological medication regimenmay be necessary to prevent irreversible visual loss caused by chroniceye conditions such as glaucoma. Many eye conditions are treated using aliquid solution that is applied directly to the eye. These liquidsolutions are commonly referred to as “eye drops.”

There are many reasons why individuals may not comply with a medicationregimen. An individual could forget to administer the medication,misunderstand the medication regimen, fail to properly apply themedication (e.g., by mistaking the amount/quantity of the dose), forgetto refill a prescription, or may simply be unable to afford themedication (and thus may never fill the prescription in the firstplace).

Severely-affected individuals (i.e., those suffering from an advancedstage of an eye condition) may be prescribed combination therapies thatare difficult to track. For example, a severely-affected individual maybe prescribed an ophthalmological medication regimen that requiresadministering timolol twice a day, dorzolamide twice a day, brimonidinetwice a day, and latanoprost once a day. Consequently, ophthalmologicalmedication regimens may require that multiple bottles of liquidmedicament be accessible in the morning, afternoon, and/or evening.

Moreover, eye drops are typically provided in multi-use containers thatmake it difficult to comply with some medication regimens. While eyedrops may also come in preservative-free containers that house one ormore liquid medicaments (also referred to as “agents”) in an approved,mixed combination, these containers are subject to additional regulationbecause they do not include separate compartments for each liquidmedicament. These containers are also not able to create variouspermutations of drugs as may be prescribed by a medical professional(e.g., an optometrist or ophthalmologist).

Introduced here, therefore, are vials containing solution(s) that can beapplied to one or both eyes. More specifically, various embodimentspertain to single-use vials that include one or more capsules containinga liquid solution (e.g., a liquid medicament). Multiple capsules withina single vial can include the same liquid solution or different liquidsolutions. The liquid solution(s) within a vial are typicallysaline-based solutions or emulsions that include a medication fortreating an eye condition (which are collectively referred to as“ophthalmic solutions”). However, in some instances the liquid solutionmay not include any medication, and could instead be intended to serveas a lubricating and/or tear-replacing solution.

A vial may include a tear-away member (or some other easily removablemember) that prevents the liquid solution from escaping, but allows anindividual (e.g., a patient or medical professional, such as a nurse orophthalmologist) to readily administer the solution. For example, someembodiments of the vial include a tear-away member composed of the samematerial as the remainder of the vial, while other embodiments of thevial include a foil cap that can be peeled off the vial.

A vial can also include one or more capsules containing the same ordifferent liquid solutions. For example, multiple capsules could bearranged within a vial so that different liquid solutions aresimultaneously or sequentially ejected as pressure is applied to thecapsules (e.g., due to an individual squeezing the vial). Multiplecapsules within a single vial could have the same or different volumes(e.g., between 15 uL and 45 uL per capsule). Moreover, multiple capsuleswithin a single vial could include liquid solutions having similar ordifferent physical characteristics (e.g., viscosity and surface tension)that affect flow, volume, etc.

The presence of multiple capsules also enables varying volumes ofdifferent liquid solutions to be accurately mixed. Such an effect allowsthe vial to achieve the same volume of a liquid solution (e.g., a liquidmedicament) as may be used, for example, in clinical trials. In someembodiments, the microfluidic flow channels leading from the capsules tothe applicator tip have different characteristics (e.g., diameters andlayout) that allow liquid solutions to be mixed with precision prior toapplication. For example, the liquid solutions within two capsules couldbe combined in a mixing ratio of 1.5:1, 2:1, 3:1, etc.

Single-dose vials may be especially useful in eliminating confusion forthose individuals who must administer different medications at multipletimes throughout the day. For instance, single-dose vials make it easierto track whether a dose of liquid solution (e.g., a liquid medicament)has been administered. Such benefits reduce the risk of prematurelyrunning out of liquid solution when compared to multi-dose bottles,which do not indicate the exact number of doses remaining. Anotherfeature of the vial is the applicator tip, which allows for improveddrop administration for those with comorbidities such as arthritis,Parkinson's disease, stroke, etc., that affect an individual's abilityto use conventional bottles/vials.

In some embodiments, multiple single-dose vials are connected to oneanother in a strip configuration. A strip may include all of the liquidsolutions that are to be applied in a day, week, etc. For example, astrip may include seven vials that correspond to each day of the week.Each vial could also be accompanied by a label that specifies certaincharacteristics (e.g., the type of liquid medicament(s) within the vialor the day/time the liquid medicament(s) should be applied). Thoseskilled in the art will recognize that a series of vials could beorganized in many different ways, including as part of a packet ofvials.

Terminology

Brief definitions of terms, abbreviations, and phrases used throughoutthe specification are given below.

Reference in this specification to “one embodiment” or “an embodiment”means that a particular feature, structure, or characteristic describedin connection with the embodiment is included in at least one embodimentof the disclosure. The appearances of the phrase “in some embodiments”are not necessarily referring to the same embodiments, nor are theynecessarily referring to separate or alternative embodiments that aremutually exclusive of one another. Various features are described thatmay be exhibited by some embodiments but not others. Similarly, variousrequirements are described that may be requirements for some embodimentsbut not others.

Unless the context clearly requires otherwise, the words “comprise” and“comprising” are to be construed in an inclusive sense rather than anexclusive or exhaustive sense (i.e., in the sense of “including, but notlimited to”). The terms “connected,” “coupled,” or any variant thereofincludes any connection or coupling between two or more elements, eitherdirect or indirect. The coupling or connection between the elements canbe physical, logical, or a combination thereof. For example, devices maybe coupled directly to one another or via one or more intermediarychannels/devices. Devices may also be coupled in such a way thatinformation can be passed there between, despite not sharing anyphysical connection with one another. The words “associate with,”meanwhile, mean connecting or relating objects, items, etc.

Where the context permits, words used in the singular sense or theplural sense may also be used in the plural sense or the singular sense,respectively. The word “or,” in reference to a list of two or moreitems, covers all of the following interpretations of the word: any ofthe items in the list, all of the items in the list, and any combinationof the items in the list. If the specification states a component orfeature “may,” “can,” “could,” or “might” be included or have acharacteristic, that particular component or feature is not required tobe included or have the characteristic in every embodiment.

The terminology used in the Detailed Description is intended to beinterpreted in its broadest reasonable manner, even though it is beingused in conjunction with certain embodiments. The terms used in thisspecification generally have their ordinary meanings in the art, in thecontext of the disclosure as a whole and in the specific context whereeach term is used. For convenience, certain terms may be highlightedusing, for example, capitalization, italics, and/or quotation marks.However, the use of highlighting has no influence on the scope andmeaning of a term. The scope and meaning of a term is the same, in thesame context, whether or not it is highlighted.

Although alternative language and synonyms may be used for some terms,special significance is not to be placed upon whether or not a term iselaborated or discussed herein. A recital of one or more synonyms doesnot exclude the use of other synonyms. The use of examples anywhere inthis specification, including examples of any terms discussed herein, isintended to be illustrative only. The examples are not intended to limitthe scope and meaning of the disclosure or of any exemplified term.Likewise, the disclosure is not limited to the various embodimentsdescribed below.

System Topology Overview

FIG. 1 depicts a conventional medication regimen that requires differentliquid solutions (some or all of which may include medications) beapplied as eye drops at different times throughout the day. Patients whohave a chronic condition, such as glaucoma, are typically required toadminister one or more medications in the form of eye drops.

A medication regimen may require that an individual (e.g., a patient oranother individual, such as a family member or medical professional)administer medication(s) one or more times per day. In fact, somemedications may be administered once per day, while other medicationsmay be administered multiple times each day. Here, for example, Lumigan®(i.e., a bimatoprost ophthalmic solution) is to be applied each evening,while Timoptic® (i.e., a timolol maleate ophthalmic solution) is to beapplied each morning and evening, and Alphagan® P (i.e., a brimonidinetartrate ophthalmic solution) is to be applied each morning, afternoon,and evening. However, medication regimens like this often causeconfusion. For example, a patient could become confused about whichmedication(s) to administer, when each medication should beadministered, how much medication should be administered, etc.

Charts have traditionally been made that include information that makesit easier for a patient to adhere to the medication regimen. Forinstance, a chart may include the name of each medication, specify thebottle size, or be color coded based on the color of the bottle or cap.This is possible because each container includes multiple doses ofmedication that are to be administered over a period of days, weeks, ormonths. That is, each container includes a sufficient volume ofmedication for multiple doses (i.e., is a “multi-dose container” or“multi-use container”).

But multi-dose containers can also be problematic for patients who needto strictly adhere to medication regimens. For example, some patientsquickly forget whether medication was administered because it can bedifficult to notice when small amounts of medication have been ejectedfrom a multi-dose container. As another example, some patientsunexpectedly run out of medication because it can be difficult todetermine how many doses remain in a multi-dose container.

FIG. 2 includes a graph illustrating that a majority of patients who areprescribed a medication regimen discontinue adherence in less than ayear. In fact, fifty percent of patients on multi-dose medicationregimens have been found to be noncompliant within four to five months,while fifty percent of patients on single-dose medication regimens havebeen found to be noncompliant within seven months. Similar non-adherencerates have been found across different types of medications, includingalpha-adrenoceptor agonists (also referred to as “alpha agonists”),beta-adrenergic blocking agents (also referred to as “beta blockers”),However, non-adherence can be particularly troublesome when theunderlying eye condition may cause irreversible damage. For example,failure to treat glaucoma could result in blindness.

FIGS. 3A-B depict single-use vials (also referred to as “single-dosevials”) containing liquid solution(s) that can be applied to one or botheyes. Each liquid solution typically includes a pre-existing medication(e.g., steroids, antihistamines, or antibiotics) that is chosen based onthe eye condition being treated. Note, however, that in some embodimentsa liquid solution does not include any medication, and could instead beintended to serve as a lubricating and/or tear-replacing solution.

FIG. 3A depicts a strip of multiple longitudinal vials 300 a-e. Eachvial 300 a-e only includes enough liquid solution for a single dose,which is the ideal volume to maximize medication concentration andminimize excess liquid (which can result in local side effects). Otherbenefits include:

-   -   The ability to easily verify which dose(s) have been        administered;    -   The presence of clear instructions affixed on or near each vial;        and    -   The ability to easily organize/track upcoming dose(s).

Each vial 300 a-e can include a tear-away member 302 a-e (or some othereasily removable member) that prevents the liquid solution fromescaping, but allows an individual (e.g., a patient or anotherindividual, such as a family member or medical professional) to readilyadminister the liquid solution(s) as eye drops. For example, someembodiments of the vial 300 a-e include a tear-away member or atwist-off member composed of the same material as the remainder of thevial, while other embodiments of the vial 300 a-e include a foil capthat can be peeled off the vial. Additionally or alternatively, a vial300 a-e could include an end member that is intended to be punctured.

Generally, the liquid solution is ejected from an applicator tip 304 a-ewhen pressure is applied to the outer surface of the vial 300 a-e (e.g.,due to an individual squeezing the vial 300 a-e). Some embodimentsinclude mechanical components (e.g., a spring mechanism, a slider, or apressure release) that cause a pressure to be applied to vial 300 a-eand/or the capsule(s) within the vial 300 a-e so that the liquidsolution is guided through a microfluidic channel to the applicator tip304 a-e. For example, rather than squeeze the vial 300 a-e, anindividual could instead press a button that activates a springmechanism, which causes at least some of the liquid solution containedin the vial 300 a-e to be ejected through the applicator tip 304 a-e.

As shown here, multiple vials 300 a-e can be connected to one another ina strip configuration. A strip may include all of the liquid solutionsthat are to be applied in a day, week, etc. Here, for example, the stripof vials 300 a-e includes two vials that are to be applied on Mondaymorning and three vials that are to be applied on Monday evening. Asanother example, strips for daily dosing regimens may include thirtyvials having squeezable compartment(s) of liquid solution(s), whilestrips for bid dosing regiments may include sixty vials havingsqueezable compartment(s) of liquid solution(s).

Multiple vials can be organized into strips in a manner that facilitatesmore consistent adherence to a medication regimen. For example, a label306 a-e could be disposed on or near each vial that indicates when theliquid solution(s) within each vial are to be applied. In someembodiments each label is affixed to the outside of the correspondingvial, while in other embodiments each label is affixed to a structuralfeature (e.g., a tab) connected to the corresponding vial. The labels306 a-e may be color coded so that a patient can more easily adhere to amedication regimen. For example, specific colors could be used tovisually distinguish certain types of medications or visually specifywhat time of day each vial should be used. The labels 306 a-e caninclude text that specifies the type of medicine, what day/date/timeeach vial should be used, whether the liquid solution is to be appliedto one or both eyes, etc.

Accordingly, each label 306 a-e could include various pieces ofinformation corresponding to a medication regimen that allow anindividual to more easily administer liquid solution(s) in accordancewith the medication regimen. Some of the information may be color codedor otherwise emphasized to highlight its importance. For instance, thename of the liquid solution may be color coded based on the color of itsoriginal, multi-dose container. The labels 306 a-e also allow themanufacturer of the vials 300 a-e and/or the liquid solution(s) withinthe vials 300 a-e to provide clear instructions on when and how theliquid solution(s) should be administered. Both the strip configurationand the presence of the labels 306 a-e make it easier to organize thevials 300 a-e and track administrations of liquid solution(s) (therebyalso monitoring adherence to a medication regimen). Additionally oralternatively, the vials 300 a-e may include an outer color coding thatvisually conveys information, such as the type of liquid solution withineach vial.

In some embodiments, each of the vials 300 a-e is removable from thestrip following administration of the liquid solution(s). For example,an indentation or perforation may exist between each pair of vials thatallows the individual to readily separate a given vial from the strip.Such a design not only makes it easier for the individual to administerthe liquid solution(s) (e.g., by handling a single vial rather than anentire strip), but also makes it easier to verify whether a dose hasbeen administered.

The vials 300 a-e may be composed of different materials based onintended use duration, exposure, etc. For example, the vials 300 a-ecould be constructed using food-grade materials such as plastic, rubber,etc. More specifically, some vials 300 a-e are composed of silicon-basedorganic polymers (e.g., polydimethylsiloxane (PDMS)) that are opticallyclear, non-toxic, and durable. As another example, the vials 300 a-ecould be constructed using light-resistant (e.g., ultraviolet-resistant)plastics that conform to certain standards for light transmission and/orprotection from contamination. As yet another example, the vials 300 a-emay be constructed of material(s) that are biocompatible, resistant tovariations in temperature, tolerant of various pH ranges, and/orchemically stable for transportation and storage. Thus, the vials 300a-e could be designed so that the entire strip is recyclable.

FIG. 3B, meanwhile, depicts an arrangement of multiple bubbles (alsoreferred to as “capsules”). Much like the longitudinal vials of FIG. 3A,the bubbles can be individually extracted from the arrangement to allowfor easier administration of the liquid solution(s) within each bubble.

In some embodiments, a bubble is designed to retain multiple liquidsolutions. Here, for example, a dual-chamber capsule is shown thatincludes a divider, which separates a first chamber including a firstliquid solution from a second chamber including a second liquidsolution. Those skilled in the art will recognize that a bubble couldinclude any number of dividers in any type of arrangement. For example,some embodiments include a cross-shaped divider that creates fourseparate chambers, while other embodiments include a T-shaped dividerthat created three separate chambers. The divider can also be used tointelligently divide the internal volume of the bubble. For example, theT-shaped divider may allow a first liquid solution to have double thevolume or a second liquid solution and a third liquid solution.

The divider can be comprised of plastic, rubber, etc. However, thedivider is typically comprised of a material having a higher tensilestrength than the housing of the bubble. Thus, when an individualapplies pressure to the bubble, the housing may deform/rupture while thedivider remains intact. Consequently, the bubbles may be functionallysimilar to the discrete capsules included in a longitudinal vial. Forexample, an individual may be able to sequentially administer multipleliquid solutions contained within a single bubble by applying varyingpressures.

FIG. 4A depicts a series of single-use vials 400 a-d that includemultiple liquid solutions in discrete capsules 402 a-h that can besimultaneously or sequentially administered. Because mixed combinationsof different medications require additional approval processes, theliquid solutions within the discrete capsules 402 a-h are kept separatefrom one another. Said another way, if multiple liquid solutionscontaining different medications were mixed, the mixed liquid solutioncould be considered a new formulation by the United States Food and DrugAdministration (FDA) (and thus be subject to clinical trials). However,rather than using discrete capsules 402 a-h for each liquid solution,some embodiments instead use multi-chambered capsules that include adivider that separates chambers including different liquid solutions.

Here, however, each vial 400 a-d can include a separate microfluidicchannel for each discrete capsule 402 a-h that prevents thecorresponding liquid solutions from mixing until entering the tear sacof the eye. Consequently, simultaneously ejecting the liquid solutionsfrom a vial 400 a-d may be substantially equivalent to administering theliquid solutions sequentially from conventional containers. For example,an individual can administer the two different liquid solutionscontained in discrete capsules 402 a-b by simply squeezing thecorresponding vial 400 a. Electronic mechanisms for controlling flowand/or mixing are purposefully left out of some embodiments in order todecrease cost and complexity, as well as eliminate one possible failurepoint for properly administering the liquid solution(s).

Multiple discrete capsules within a vial could have the same ordifferent volumes. For example, some vials could include two discretecapsules having a volume of 15 microliters (μl) (i.e., 30 μl totalvolume), while other vials could include three discrete capsules havinga volume of 15 μl (i.e., 45 μl total volume). Those skilled in the artwill recognize that the volume of each discrete capsule may vary basedon the amount of liquid solution necessary to treat the eye condition.Generally, the discrete capsules vary in volume from 15 μl to 45 μl.Moreover, the discrete capsules within a single vial could have the samevolume or different volumes.

A small, extended applicator tip 404 a-d aids in more accurate dropplacement and more precise release of drops having a certain size. Theapplicator tips 404 a-d could be designed based on one or severalconstraints. For example, an applicator tip may be sufficiently narrowso that one or more drops are dispensed when an individual appliespressure to the outer surface of the vial 400 a-d. More specifically,the length of the applicator tip may be designed to that the capillarysurface tension maintains a substantially continuous flow of liquidsolution in approximately 10-15 μl drops, much like a micropipette,rather than the 40-50 μl drops created by conventional droppers.

However, those skilled in the art will recognize the other volumes(e.g., 5-10 μl or 25-30 μl) may also be desirable, and the applicatortips 404 a-d may be designed to consistently produce drops of thosesizes. Consequently, in some embodiments the microfluidic flow channelsleading from the discrete capsules 402 a-h to the applicator tips 404a-d have different characteristics that allow drops of different sizesto be mixed/dispensed with precision. For example, an applicator tipconfigured to dispense larger drops may have a dispersal cavity having alarger diameter or could be connected to microfluidic channel(s) havinglarger diameters.

Various embodiments of the applicator tips 404 a-d may also include acurved shape to rest over the dome of an individual's nose, a bluntedtip to avoid scraping an individual's cornea, etc. Moreover, the lengthof each applicator tip 404 a-d may be such that the capillary surfacetension maintains a substantially continuous flow of liquid solution(and, thus, a substantially consistent concentration of medicine withinthe ejected liquid solution). Other delivery mechanisms could also beused.

The applicator tips 404 a-d may be designed to facilitate more effectiveadministration of the liquid solution(s) within the vial. For example,the applicator tips 404 a-d can be designed to minimize the mixing oftwo or more liquid solutions before administration into the eye. Asanother example, the applicator tips 404 a-d can be designed to beginmixing two or more liquid solutions immediately before (e.g., by mergingmultiple microfluidic channels) or after (e.g., by directing the outputof multiple microfluidic channels into a single stream) dispersal fromthe applicator tip 404 a-d. Other embodiments of the applicator tips 404a-d can be designed to minimize risk of eye abrasion, ensure minimalloss of liquid solution (e.g., liquid solution can be administereddirectly into the eye regardless of hand-eye coordination or vialorientation), etc. For example, some applicator tips 404 a-d arepartially or entirely composed of a softer hydrophobic polymer that isnon-abrasive if contact is made with the eye.

In some embodiments, the applicator tips 404 a-d are removable from aninterface of the vial that exposes the microfluidic channel(s) leadingto the discrete capsule(s). For example, an applicator tip could bedetachably connected using an adhesive, screwed onto complementarythreads on the interface, snapped onto complementary mechanical features(e.g., protrusions, cavities, clips) on the interface, etc. Thus, anapplicator tip could be cleanable and reusable (e.g., a single reusableapplicator tip could be provided with a strip of multiple vials). Insome embodiments, the applicator tip is comprised of a flexible material(e.g., rubber) that allows the individual to administer liquidsolution(s) with precision.

FIG. 4B depicts how microfluidic flow channels can be used to guideliquid solution from one or more discrete capsules to an applicator tip.In some embodiments, all of the discrete capsules within a given vialmay dispense their corresponding liquid solutions simultaneously. Asnoted above, in such embodiments the liquid solutions may mix beforebeing ejected from the applicator tip (e.g., within microfluidicchannels leading from each discrete capsule to the applicator tip) or asthe liquid solutions are being ejected by the applicator tip. Such aconfiguration is referred to as a “one-squeeze delivery.” Themicrofluidic flow channels may have different characteristics (e.g.,diameters and layout) that allow liquid solutions from multiple discretecapsules to be mixed with precision. For example, the diameters of twomicrofluidic flow channels may vary based on whether the mixing ratioshould be 1:1, 1.5:1, 2:1, 3:1, etc.

In other embodiments, the discrete capsules and microfluidic flowchannels are arranged so that the liquid solutions are dispensedsubstantially sequentially. However, there may be some mixing of theliquid solutions due to, for example, residual liquid left behindfollowing administration of a first liquid solution in a microfluidicchannel and/or applicator tip. Sequential administration of the liquidsolutions could be accomplished in a number of ways. For example,multiple discrete capsules could be arranged sufficiently far apart fromone another within a vial such that an individual can apply pressure toeach capsule individually. As another example, the multiple capsules maybe made of materials having different tensile strengths (also referredto as “breaking strengths”), so the application of a slight pressure mayonly cause one capsule to break (and, thus, one liquid solution to beejected). Sequential administration may be particularly desirable whenit is preferable to have some amount of time (e.g., a minute or severalminutes) between administrations of different liquid solutions.

Although a series of single-dose vials may be initially arranged in astrip configuration, each vial may be separately removable from thestrip. For example, the strip may include indentations or perforationsthat allow individual vials to be readily detached from the strip.Accordingly, once the liquid solution(s) within a given vial have beenadministered, an individual could remove and dispose of that given vialwhile the other vials remain affixed in the strip.

FIG. 5 depicts a flow diagram of a process 500 for manufacturingsingle-dose vials that include one or more discrete capsules, which eachinclude a liquid solution to be administered by an individual.

A substrate is initially retrieved that can be readily molded into oneor more vials (step 501). As further described below, in someembodiments, the substrate is initially in the form of nurdles/resin,and thus must be fed into an extruder that melts the nurdles/resin andforms the melted resin. As shown above in FIG. 3B, the substrate couldbe an FDA-grade bubble wrap having a silicone coating that includes ananti-microbial additive (e.g., a fluorinated additive) to impedemicrobial growth/development. The FDA-grade bubble wrap can be comprisedof substantially 100% virgin resin, such as polyethylene (PE) orpolypropylene (PP).

A liquid solution can then be injected into each of one or more discretecapsules (step 502). The capsule(s) could include the same liquidsolution, similar liquid solutions, or different liquid solutions. Forexample, the capsule(s) could include different medications or differentconcentrations of the same medicine.

The capsule(s) can then be arranged on the substrate (step 503). Thecapsule(s) are typically arranged so that the liquid solution withineach capsule will be ejected as pressure is applied to the correspondingcapsule. For example, each capsule could be connected to a microfluidicchannel that carries liquid solution form the capsule to an applicatortip that ejects the liquid solution (e.g., in 10-15 μl drops).

A vial can then be formed that houses the capsule(s) (step 504).Generally, the vial is made using a pliable material (e.g., plastic)that bends when pressure is applied to the outer surface of the vial,which causes pressure to then be applied to some or all of thecapsule(s). In some embodiments, the vial also includes one or moremechanisms (e.g., mechanical sliders or puncture features) that allowsthe liquid solution within each capsule to be individually administered.

Moreover, each discrete capsule can be connected to an applicator tip(or an output end capable of interfacing with a detachable applicatortip) via a microfluidic flow channel. Each discrete capsule could be,for example, 10-20 μl. Accordingly, a vial including two capsules mayinclude 20-40 μl of fluids (as well as two microfluidic flow channels)and a vial including three capsules may include 30-60 μl (as well asthree microfluidic flow channels).

The capsule(s) and/or the vial could be produced via standardmanufacturing processes. For example, a virgin resin (e.g., polyethyleneor polypropylene) could be extruded and melted using a vacuum, and thenpassed through a roller to reduce the virgin resin to a desiredthickness. The processed virgin resin can then be vacuumed to apredefined mold having the desired cavity size (e.g., 1/16″ thick by ⅛″diameter). Once the cavities have been molded, the entire sheet can bepassed through sterile hood(s) where medication can be injected inappropriate aliquots into the cavities. Another layer of virgin resincan then be affixed to the molded layer of virgin resin and used to sealthe capsules. Both layers of virgin resin may be placed under thesterile hood(s) and bonded together (e.g., by a mechanical press and/orcuring fixtures) prior to segmenting the vials. In some embodiments, acoating (e.g., an antimicrobial coating) is applied to the outer surfaceof both layers of virgin resin.

In some embodiments, multiple vials are left connected to one another toform a strip (step 505). The term “strip” includes row configurationsand sheet configurations from which individual vials can be sequentiallyextracted. For example, a sheet configuration may be substantiallysimilar to the configuration of bubble wrap. This allows individuals(e.g., patients and other individuals, such as family members andmedical professionals) to easily keep track of which dose(s) have beenadministered. Said another way, the strip configuration may make iteasier to monitor compliance with a medication regimen.

The number of doses can be labeled sequentially (e.g., first dose,second dose, etc.), temporally (e.g., morning and/or evening), etc.Thus, the concentrations of liquid medicament in a strip of vials mayvary (e.g., concentration may decrease over time). Also may haveequivalent labeling/markings for foreign languages.

FIG. 6 depicts a flow diagram of a process 600 for administering aliquid solution (e.g., a saline-based solution that includes amedication) from a single-dose vial. An individual initially acquires avial that includes one or more capsules containing a liquid solution tobe administered (step 601). In some embodiments, the vial is one ofmultiple vials that are connected to one another. The multiple vials mayinclude the same liquid solution or different liquid solutions. Forexample, the multiple vials may include liquid solutions having varyingconcentrations of a medication. The multiple vials may be designed suchthat the individual can easily administer the liquid solution withineach vial over a period of times. Accordingly, if the vial is one ofmultiple vials that are connected to one another (e.g., in a strip), theindividual can detach the vial (step 602).

The individual can then position the vial over one of the eyes (step603). Generally, the vial will only include enough liquid solution foradminister into one eye. However, in some instances the vial may includeenough liquid solution for the individual to sequentially administer theliquid solution into each eye. After the vial has been arranged over theeye, pressure can be applied to the outer surface of the vial (step604). More specifically, pressure can be applied to the capsule withinthe vial that causes the liquid solution to flow from the capsule to anapplicator tip via a microfluidic channel (e.g., the capsule may burst,deform, or be punctured). For example, the individual (e.g., a patientor medical professional, such as a nurse or ophthalmologist) may squeezethe vial itself or press a button that causes a mechanism to apply thepressure.

Moreover, in some embodiments, the vial itself is designed so that theliquid solution can be readily applied by an individual who suffersfrom, for example, poor dexterity, arm strength, or hand-eyecoordination. For example, the vial may be designed so that it can reston the individual's nose and naturally be arranged over one or botheyes. Application of the pressure causes liquid solution to be dispensedfrom some or all of the capsule(s) housed within the vial. Morespecifically, each liquid solution travels from the correspondingcapsule to the applicator tip via a microfluidic channel, and then isejected from the applicator tip (step 605). The applicator tip may bedesigned to consistently eject drop of substantially the size (e.g.,10-15 μl).

Unless contrary to physical possibility, it is envisioned that the stepsdescribed above may be performed in various sequences and combinations.For instance, the patient could detach the vial from a strip of multiplevials before or after administering the liquid solution(s) containedwithin the vial. Other steps could also be included in some embodiments.For example, some liquid solutions may require the individual perform anaction (e.g., shaking the vial) prior to administration of the liquidsolution to the eye.

Remarks

The foregoing description of various embodiments of the claimed subjectmatter has been provided for the purposes of illustration anddescription. It is not intended to be exhaustive or to limit the claimedsubject matter to the precise forms disclosed. Many modifications andvariations will be apparent to those skilled in the art. Embodimentswere chosen and described in order to best describe the principles ofthe technology and its practical applications, thereby enabling othersskilled in the relevant art to understand the claimed subject matter,the various embodiments, and the various modifications that are suitedto the particular uses contemplated.

No matter how detailed the specification appears, embodiments of thetechnology can be practiced in many ways. Details of the technology mayvary considerably in its implementation details while still beingencompassed by the specification. As noted above, particular terminologyused when describing certain features or aspects of various embodimentsshould not be taken to imply that the terminology is being redefinedherein to be restricted to any specific characteristics, features, oraspects with which that terminology is associated. In general, the termsused in the following claims should not be construed to limit thetechnology to the specific embodiments disclosed in the specification,unless those terms are explicitly defined herein. Accordingly, theactual scope encompasses not only the disclosed embodiments, but alsoall equivalent ways of practicing or implementing the technology thatare covered by the claims.

The language used in the specification has been principally selected forreadability and instructional purposes, and it may not have beenselected to delineate or circumscribe the inventive subject matter. Itis therefore intended that the scope not be limited by thespecification, but rather by any claims that issue on an applicationbased hereon. Accordingly, the disclosure of various embodiments isintended to be illustrative, but not limiting, of the scope of thetechnology.

What is claimed is:
 1. An apparatus comprising: a vial that includes a substantially transparent housing, multiple fluid containers disposed in the substantially transparent housing, wherein each fluid container of the multiple fluid containers contains a different ophthalmic solution, and a flow channel through which ophthalmic solution is guided when pressure is applied to the substantially transparent housing that causes deformation of at least one fluid container; and an applicator tip from which ophthalmic solution is ejected in the form of droplets.
 2. The apparatus of claim 1, wherein the multiple fluid containers are comprised of materials having different tensile strengths, which enables the different ophthalmic solutions contained in the multiple fluid containers to be sequentially administered in response to applications of different pressures.
 3. The apparatus of claim 1, wherein the multiple fluid containers are comprised of materials having substantially similar tensile strengths, which enables the different ophthalmic solutions contained in the multiple fluid containers to be simultaneously administered in response to an application of pressure.
 4. The apparatus of claim 1, wherein the applicator tip is detachably connectable to a physical interface of the substantially transparent housing.
 5. The apparatus of claim 1, wherein the multiple fluid containers are representative of chambers of a rupturable capsule that are separated by a divider, and wherein the divider is comprised of a material having a higher tensile strength that the rupturable capsule so that when pressure is applied to the substantially transparent housing, the divider remains intact when the capsule ruptures.
 6. The apparatus of claim 1, wherein the flow channel is one of multiple flow channels, and wherein each fluid container of the multiple fluid containers is connected to a corresponding flow channel of the multiple flow channels in fluid communication with the applicator tip.
 7. The apparatus of claim 1, wherein the applicator tip is designed such that the different ophthalmic solutions contained in the multiple fluid containers mix before ejection from the applicator tip.
 8. The apparatus of claim 1, wherein the applicator tip is designed such that the different ophthalmic solutions contained in the multiple fluid containers mix after ejection from the applicator tip.
 9. The apparatus of claim 1, wherein each fluid container of the multiple fluid containers includes 15 microliters to 45 microliters of ophthalmic solution.
 10. An apparatus comprising: an arrangement of multiple vials oriented in a given direction, wherein each vial of the multiple vials includes a housing, a fluid container disposed in the housing that contains an ophthalmic solution, and a flow channel through which the ophthalmic solution is guided when pressure is applied to the housing that causes deformation of the fluid container; and multiple applicator tips from which ophthalmic solution is ejected from the multiple vials in the form of droplets.
 11. The apparatus of claim 10, wherein perforations are interposed among the multiple vials to allow the multiple vials to be detached from one another.
 12. The apparatus of claim 10, wherein each vial of the multiple vials is associated with a label that includes information regarding the ophthalmic solution contained therein.
 13. The apparatus of claim 12, wherein the information specifies a type of ophthalmic solution contained in a corresponding vial, a day, date, or time at which the ophthalmic solution in the corresponding vial is to be administered, or an eye into which the ophthalmic solution in the corresponding vial is to be administered.
 14. The apparatus of claim 12, wherein each label is affixed to a tab connected to the housing of a corresponding vial.
 15. The apparatus of claim 12, wherein each label is affixed to the housing of a corresponding vial.
 16. A method of manufacturing single-dose vials that contain ophthalmic solution, the method comprising: acquiring a first substrate comprised of virgin resin; vacuuming the first substrate onto a predefined mold to form a molded substrate having multiple cavities; passing the molded substrate through a sterile hood; injecting an ophthalmic solution into each cavity of the multiple cavities of the molded substrate; and bonding a second substrate comprised of virgin resin to the molded substrate to form single-dose vials that contain ophthalmic solution.
 17. The method of claim 16, wherein the ophthalmic solution injected into each cavity of the multiple cavities is the same ophthalmic solution.
 18. The method of claim 16, wherein said acquiring comprises: retrieving nurdles comprised of virgin resin; melting the nurdles to create melted virgin resin; and passing the melted virgin resin through a roller to form the first substrate having a desired thickness.
 19. The method of claim 16, further comprising: adding an anti-microbial additive to the first and second substrates to impede microbial growth.
 20. The method of claim 16, wherein the ophthalmic solution injected into each cavity of the multiple cavities is a saline-based solution or an emulsion that includes a liquid medicament for treating an ocular condition. 